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大输液在临床治疗中有广泛的应用 ,制剂质量的优劣直接影响用药的安全有效。因此 ,在大输液配制过程中质量控制至关重要。本文对 12 3批次自制大输液成品 1~ 2 0瓶 (简称首瓶 )的澄明度、不溶性微粒、热原、无菌检查、含量进行了系统检查 ,根据其变化规律 ,提出几点质量控制措
Large infusion in clinical treatment has a wide range of applications, the quality of the preparation of a direct impact on the safety and efficacy of the drug. Therefore, quality control is of paramount importance in the formulation of large transfusion fluids. In this paper, 12 3 batches of homemade infusion of finished products 1 to 20 bottles (referred to as the first bottle) of clarity, insoluble particles, pyrogen, aseptic inspection, the content of a systematic inspection, according to its variation, put forward some quality control Measures